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  • Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with rou…

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Clinical trial
Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic based or telehealth follow-up, after completion of first line chemotherapy in patients with epithelial ovarian cancer
  1. Paul A Cohen1,2,3,
  2. Penelope M Webb4,
  3. Madeleine King5,
  4. Andreas Obermair6,
  5. Val Gebski7,
  6. Phyllis Butow8,9,
  7. Rachael Morton7,
  8. Wanda Lawson10,
  9. Patsy Yates11,
  10. Rachel Campbell5,
  11. Tarek Meniawy12,
  12. Michelle McMullen12,
  13. Andrew Dean13,
  14. Jeffrey Goh14,15,
  15. Orla McNally16,17,
  16. Linda Mileshkin18,19,
  17. Philip Beale20,
  18. Rhonda Beach10,
  19. Jane Hill21,
  20. Cyril Dixon21,
  21. Sue Hegarty21,
  22. Jim Codde3,
  23. Angela Ives22,
  24. Yeh Chen Lee23,24,
  25. Alison Brand25,26,
  26. Anne Mellon27,
  27. Sanela Bilic1,
  28. Isobel Black1,
  29. Stephanie Jeffares1 and
  30. Michael Friedlander23,28
  1. 1Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia
  2. 2Division of Obstetrics and Gynaecology, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia
  3. 3Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia
  4. 4Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia
  5. 5Faculty of Science, School of Psychology, University of Sydney, Faculty of Science, Sydney, New South Wales, Australia
  6. 6Gynaecological Cancer Research, The University of Queensland, Brisbane, Queensland, Australia
  7. 7NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
  8. 8Psycho-oncology Co-operative Research Group (PoCoG), School of Psychology, University of Sydney, Sydney, New South Wales, Australia
  9. 9Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, The University of Sydney, Sydney, New South Wales, Australia
  10. 10Australia and New Zealand Gynaecological Oncology Group, Sydney, New South Wales, Australia
  11. 11Faculty of Health, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Queensland, Australia
  12. 12Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
  13. 13Bendat Family Comprehensive Cancer Centre, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia
  14. 14Department of Oncology, Royal Brisbane & Women’s Hospital, Herston, Queensland, Australia
  15. 15Faculty of Medicine, University of Queensland, St Lucia, Queensland, Australia
  16. 16Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia
  17. 17Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia
  18. 18Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
  19. 19The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia
  20. 20Cancer Services, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
  21. 21Ovarian Cancer Australia, Melbourne, Victoria, Australia
  22. 22Division of Surgery, The University of Western Australia Faculty of Health and Medical Sciences, Perth, Western Australia, Australia
  23. 23Prince of Wales Clinical School, University of New South Wales, Randwick, New South Wales, Australia
  24. 24Medical Oncology, Prince of Wales and Royal Hospital for Women, Randwick, New South Wales, Australia
  25. 25Department of Gynaecological Oncology, Westmead Hospital, Sydney, New South Wales, Australia
  26. 26Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia
  27. 27Hunter New England Centre for Gynaecological Cancer, John Hunter Hospital, New Lambton Heights, New South Wales, Australia
  28. 28Medical Oncology, Prince of Wales Hospital, Sydney, New South Wales, Australia
  1. Correspondence to Dr Paul A Cohen, Department of Gynaecological Oncology, St John of God Subiaco Hospital, Subiaco, Western Australia, Australia; paul.cohen{at}uwa.edu.au

Abstract

Background Physical symptoms, anxiety, depression, fear of recurrence, sexual dysfunction, and social withdrawal are common in women after treatment for ovarian cancer. Most patients would like and need help dealing with these symptoms. The traditional model of follow-up care is unstructured and largely focused on diagnosing recurrent disease, and most oncologists lack skills to identify and manage psychosocial issues. No high quality prospective clinical trials have been conducted to determine the optimal follow-up regimen or the cost effectiveness of ovarian cancer surveillance strategies.

Primary Objective(s) To assess emotional wellbeing, acceptability, safety, and cost effectiveness of nurse led follow-up via telehealth for women with ovarian cancer following completion of primary treatment.

Study Hypothesis We hypothesize that compared with routine clinic based follow-up, nurse led follow-up via telehealth, including serum CA125 monitoring and completion of a patient reported outcome instrument, the Measure of Ovarian Symptoms and Treatment concerns-Surveillance (MOST-S26), will improve emotional wellbeing in women with ovarian cancer; be feasible, safe, acceptable, and not delay the time to diagnosis of recurrent disease; will result in greater patient satisfaction; will identify more patients with psychological distress, lead to better care, and improved psychological outcomes; and be cost-effective.

Trial Design Phase II multicenter randomized trial comparing 3 monthly nurse led telehealth consultations that include serum CA125 monitoring and completion of the MOST-S26, with routine clinic based follow-up. The allocation ratio will be 1:1.

Major Inclusion/Exclusion Criteria Eligible patients will be women with high grade epithelial ovarian cancer who have normalized serum CA125 (to <35 kU/L) at completion of first line chemotherapy.

Primary Endpoint(s) Emotional wellbeing at 12 months.

Sample Size 150 patients.

Estimated Dates for Completing Accrual and Presenting Results July 2023. Results expected in 2025, 24 months after the last participant is enrolled.

Trial Registration ACTRN12620000332921

  • ovarian cancer
  • quality of life (PRO)/palliative care

Data availability statement

There are no data in this work.

https://doi.org/10.1136/ijgc-2021-002999

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    Data availability statement

    There are no data in this work.

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    Footnotes

    • Contributors Substantial contributions to the conception or design: all authors. PAC is the principal investigator of the trial and drafted the manuscript. Drafting the work and revising it critically for important intellectual content: all authors. Final approval of the version published: all authors. Agreement to be accountable for all aspects of the work: all authors.

    • Funding The study is funded by the Western Australia Health Translation Network’s Health Service Translational Research Project Grant, the Australian Government’s Medical Research Future Fund, the Australia and New Zealand Gynaecological Oncology Group (ANZGOG), and the Ladybird Foundation.

    • Competing interests PAC reports honoraria from Seqirus and Astra Zeneca unrelated to the submitted work. AO reports grants, personal fees, and other funding from SurgicalPerformance PTY Ltd, and grants from Medtronic, not directly related to the subject of this manuscript; consultancy fees from Baxter Healthcare Australia and New Zealand and Astra Zeneca Australia, not directly related to the subject of this manuscript; and a trademark licensed to SurgicalPerformance Pty Ltd. PB reports honoraria from GSK. MF reports grants from Astra Zeneca, Novartis, and Beigene; consulting fees from Astra Zeneca, Novartis, GSK, MSF, Takeda, and Lilly; honoraria from Astra Zeneca, GSK, and ACT Genomics; and support for travel from Astra Zeneca, unrelated to the submitted work. MK, MF, PMW, RC, and PAC developed the MOST-S26.

    • Provenance and peer review Commissioned; internally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.